The purpose of this study is to evaluate the safety and toleration of oral sildenafil administered as required by women with Female Sexual Arousal Disorder (FSAD) who successfully complete one of the following Pfizer-sponsored, 12-week, double-blinded clinical trials: A1481082 or A1481123. Addition of this 52-week open-label extension will increase the total duration of sildenafil exposure to 64 weeks. Sustained efficacy will also be evaluated after 3 and 6 months of open-label therapy.

An Open-Label, Multi-Center Extension Study To Evaluate The Safety, Toleration And Sustained Efficacy Of Oral Sildenafil Administered To Women Who Have Been Diagnosed With Female Sexual Arousal Disorder

The score for each of the individual questions 3,5 and 9 on the SQoL-F [ Time Frame: Week 14 and Week 26 ] [ Designated as safety issue: No ]

The total satisfaction score on the Inventory of Treatment Satisfaction (ITS-modified EDITS) [ Time Frame: Week 14 and Week 26 ] [ Designated as safety issue: No ]

The score for each of the individual questions 3,5,6 and 7 on the ITS-modified EDITS [ Time Frame: Week 14 and Week 26 ] [ Designated as safety issue: No ]

The Arousal-lubrication Domain from the SFQ. The score for this domain is the sum of scores from Questions 11 and 12 from the SFQ [ Time Frame: Week 14 and Week 26 ] [ Designated as safety issue: No ]

The Arousal-sensation Domain from the SFQ. The score for this domain is sum of scores from Questions 7,8,9 and 10 from the SFQ. [ Time Frame: Week 14 and Week 26 ] [ Designated as safety issue: No ]

The total Quality of Life score on the Sexual Quality of Life (SQoL-F) [ Time Frame: Week 14 and Week 26 ] [ Designated as safety issue: No ]

The Desire domain from the SFQ. Specifically, the sum of scores from questions 1,2,3,4,15 and 28 (frequency of pleasurable thoughts, wanted to be touched, wanted sex, initiated sex, had sex with penetration, looked forward to sex, respectively). [ Time Frame: Week 14 and Week 26 ] [ Designated as safety issue: No ]

Question 16 from the SFQ at Weeks 14 and 26 (enjoyment of penetration and intercourse). [ Time Frame: Week 14 and Week 26 ] [ Designated as safety issue: No ]

The Orgasm domain from the SFQ. The score for this domain is the sum of scores from questions 24,25 and 26 (orgasm frequency, level of pleasure and ease in achieving, respectively). [ Time Frame: Week 14 and Week 26 ] [ Designated as safety issue: No ]

The individual questions of the Orgasm domain. [ Time Frame: Week 14 and Week 26 ] [ Designated as safety issue: No ]

sildenafil 50 mg (starting dose) tablet by mouth taken as needed 1 hour before anticipated sexual activity; the dose could be increased to 100 mg or decreased to 25 mg; the duration of therapy in this open-label study was 52 weeks

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Included were subjects who completed Pfizer study A1481082 or A1481123 without a major protocol violation and with all treatment-related adverse events resolved prior to crossover into the open-label study.

For subjects receiving hormone replacement therapy and/or selective serotonin reuptake inhibitor treatment, dosage of these must be stable at the start of this extension study and remain stable throughout.

Subjects should continue to maintain a stable sexual relationship throughout the study.

Exclusion Criteria:

Excluded were subjects who experienced either treatment-related serious adverse events or significant treatment-related laboratory abnormalities in the previous study, and subjects who misused study medication and/or failed to adequately account for study medication in the previous study, or who were non-compliant with visits.

Also excluded were subjects who were currently prescribed and/or taking nitrates or nitric oxide donors in any form (oral, sublingual, buccal, transdermal, inhalational or aerosols).

Contacts and Locations

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For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746967